- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03443206
Loves Company: Combatting Emotional Disturbance in the Digital Age
April 8, 2022 updated by: Anna Van Meter, Northwell Health
The goal of this study is to determine whether a community-based website that is intended to provide support for adolescents experiencing psychological distress can improve members' mental health outcomes.
The investigators want to understand if a digital platform can help young people who are suffering and may be unlikely to access more traditional forms of mental health services.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
212
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Glen Oaks, New York, United States, 10011
- Northwell Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 14-17
- Access to internet-connected device
- Residing in the United States
Exclusion Criteria:
*Inability to assent due to intellectual disability or lack of English language skills
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
This condition will include access to a website that includes a social component, in addition to psychoeducation and access to resources.
|
Participants randomized to the intervention condition will be able to communicate with one another and offer social media-based forms of support (e.g., post music, photos, etc).
educational materials related to mental health
links to online mental health resources
|
Active Comparator: Control
This condition will include access to a website that includes psychoeducation and access to resources.
|
educational materials related to mental health
links to online mental health resources
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adolescent Suicidal Ideation Measure score
Time Frame: 6 months
|
frequency of suicidal thoughts and behaviors
|
6 months
|
Perceived burdensomeness and hopelessness scale score
Time Frame: 6 months
|
lower burdensomeness and hopelessness in treatment group (lower score better)
|
6 months
|
General Behavior Inventory 10D (GBI 10D)
Time Frame: 6 months
|
symptoms of depression lower in treatment group (lower score)
|
6 months
|
Life Satisfaction
Time Frame: 6 months
|
level of satisfaction with quality of life
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adolescent Suicidal Ideation Measure score
Time Frame: 12 months
|
frequency of suicidal thoughts and behaviors
|
12 months
|
Perceived burdensomeness and hopelessness scale score
Time Frame: 12 months
|
lower burdensomeness and hopelessness in treatment group (lower score better)
|
12 months
|
General Behavior Inventory 10D (GBI 10D)
Time Frame: 12 months
|
symptoms of depression lower in treatment group (lower score)
|
12 months
|
Life Satisfaction
Time Frame: 12 months
|
level of satisfaction with quality of life
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
site engagement
Time Frame: 6 months
|
time spent on site
|
6 months
|
General Behavior Inventory 10D (GBI 10D)
Time Frame: weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
|
changes in depressive symptoms
|
weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
|
Perceived burdensomeness and hopelessness scale score
Time Frame: weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
|
change in burdensomeness and hopelessness
|
weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Barzilay S, Feldman D, Snir A, Apter A, Carli V, Hoven CW, Wasserman C, Sarchiapone M, Wasserman D. The interpersonal theory of suicide and adolescent suicidal behavior. J Affect Disord. 2015 Sep 1;183:68-74. doi: 10.1016/j.jad.2015.04.047. Epub 2015 May 7.
- Bearman PS, Moody J. Suicide and friendships among American adolescents. Am J Public Health. 2004 Jan;94(1):89-95. doi: 10.2105/ajph.94.1.89.
- Belfer ML. Child and adolescent mental disorders: the magnitude of the problem across the globe. J Child Psychol Psychiatry. 2008 Mar;49(3):226-36. doi: 10.1111/j.1469-7610.2007.01855.x. Epub 2008 Jan 21.
- Birnbaum ML, Candan K, Libby I, Pascucci O, Kane J. Impact of online resources and social media on help-seeking behaviour in youth with psychotic symptoms. Early Interv Psychiatry. 2016 Oct;10(5):397-403. doi: 10.1111/eip.12179. Epub 2014 Sep 9.
- Brissette I, Scheier MF, Carver CS. The role of optimism in social network development, coping, and psychological adjustment during a life transition. J Pers Soc Psychol. 2002 Jan;82(1):102-11. doi: 10.1037//0022-3514.82.1.102.
- Gould MS, Velting D, Kleinman M, Lucas C, Thomas JG, Chung M. Teenagers' attitudes about coping strategies and help-seeking behavior for suicidality. J Am Acad Child Adolesc Psychiatry. 2004 Sep;43(9):1124-33. doi: 10.1097/01.chi.0000132811.06547.31.
- Heflinger CA, Hinshaw SP. Stigma in child and adolescent mental health services research: understanding professional and institutional stigmatization of youth with mental health problems and their families. Adm Policy Ment Health. 2010 Mar;37(1-2):61-70. doi: 10.1007/s10488-010-0294-z.
- La Greca AM, Harrison HM. Adolescent peer relations, friendships, and romantic relationships: do they predict social anxiety and depression? J Clin Child Adolesc Psychol. 2005 Mar;34(1):49-61. doi: 10.1207/s15374424jccp3401_5.
- Maher CA, Lewis LK, Ferrar K, Marshall S, De Bourdeaudhuij I, Vandelanotte C. Are health behavior change interventions that use online social networks effective? A systematic review. J Med Internet Res. 2014 Feb 14;16(2):e40. doi: 10.2196/jmir.2952.
- McGorry P, Bates T, Birchwood M. Designing youth mental health services for the 21st century: examples from Australia, Ireland and the UK. Br J Psychiatry Suppl. 2013 Jan;54:s30-5. doi: 10.1192/bjp.bp.112.119214.
- Safer DJ. Self-reported suicide attempts by adolescents. Ann Clin Psychiatry. 1997 Dec;9(4):263-9. doi: 10.1023/a:1022364629060.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2020
Primary Completion (Actual)
July 31, 2021
Study Completion (Actual)
July 31, 2021
Study Registration Dates
First Submitted
February 2, 2018
First Submitted That Met QC Criteria
February 16, 2018
First Posted (Actual)
February 23, 2018
Study Record Updates
Last Update Posted (Actual)
April 11, 2022
Last Update Submitted That Met QC Criteria
April 8, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0062-ZHH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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